Astellas combo bladder cancer therapy licensed by MHRA

In what Astella Pharma (TYO: 4503) calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for Padcev (enfortumab vedotin), an antibody-drug conjugate [ADC]) in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.

The indication is based on results of the Phase III EV-302 clinical trial (also known as KEYNOTE-A39). The Phase III clinical trial showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.